奥美拉唑肠溶胶囊在健康人体药动学及生物等效性研究

目的研究两个不同厂家生产的奥美拉唑肠溶胶囊在健康人体的生物等效性。方法20名健康志愿者采用双周期交叉试验。高效液相色谱法测定血清中奥关拉唑浓度。血药浓度-时间数据采用DAS2．0统计软件处理，计算主要药代动力学参数，并进行两种制剂的生物等效性评价。结果受试制剂及参比制剂的主要药代动力学参数t，小Cmax、Tmax；和AUC0—12h分别为（1．79±0．86）h和（1．49±0．50）h、（0．51±0．25）μg·mL^-1和（0．49±0．19）μg·mL^-1、（2．05±0．64）h和（2．04±0．63）h、（1．64±1．41）μg·h～·mL^-1和（1．57±0．99）μg·h^-1·mL^-1。受试制剂的相对生物利用度为（101．48±33．82）％。结论两种奥关拉唑肠溶胶囊具有生物等效性。

OMEPRAZOLE ENTERIC-COATED CAPSULES IN HEAL THY VOLUNTEERS PHARMACOKINETICS AND BIOEQUIVALENCE STUDIES

Objective To investigate the bioequivalence of omeprazole enteric -coated capsules made in two factories in Chinese healthy volunteers. Methods Twenty volunteers were randomly divided into two groups（ experiment and control） , with double cross over design. The concentration of omeprazole in serum was determined by high performance liquid chromatography （HPLC） and pharmacokinetic parameters were calculated with DAS 2.0 practical pharmacokinetics program. Results The pharmacokinetic parameters of the experiment and control groups were as follows ： t1/2 were （ 1.79± 0.86 ） h and （ 1.49 ± 0.50 ） h respectively ; Cmax were （ 0.51 ± 0.25 ） μg · mL^ - 1 and （ 0.49 ± 0.19 ） μg ·mL^ -1 respectively , Tmax were （ 2.05 ± 0.64 ） h and （ 2.04 ±0. 63 ） h respectively, AUC0 - 12h were（ 1.64 ± 1.41 ） μg · h^-· mL^-1 and （ 1.57±0.99） μg· h^-1· mL^-1 ,respectively. The relative bioavailability of the test preparation was （ 101.48 ± 33.82） % . Conclusion The statistical analysis showed that the experiment and control preparations were bioequivalent.